Transcript

• Predsol Retention Enema is a steroid
medicine, prescribed for many different
conditions, including serious illnesses.
• You need to use it regularly to get the
maximum benefit.
• Don’t stop using this medicine without talking
to your doctor – you may need to reduce the
dose gradually.
• Predsol Retention Enema can cause side
effects in some people (read section 4 on side
effects below). Some problems such as mood
changes (feeling depressed or ‘high’), or
stomach problems can happen straight away.
If you feel unwell in any way, keep using your
medicine, but see your doctor straight away.
• Some side effects only happen after weeks or
months. These include weakness of arms and
legs, or developing a rounder face (read
section 4 on side effects for more
information).
• If you use it for more than 3 weeks, you will
get a blue ‘steroid card’: always keep it with
you and show it to any doctor or nurse
treating you.
• Keep away from people who have chicken
pox or shingles, if you have never had them.
They could affect you severely. If you do come
into contact with chicken pox or shingles, see
your doctor straight away.
• Now read the rest of this leaflet. It includes
other important information on the safe and
effective use of this medicine that might be
especially important for you.
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.

• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Predsol Retention Enema is and what it
is used for
2. What you need to know before you use
Predsol Retention Enema
3. How to use Predsol Retention Enema
4. Possible side effects
5. How to store Predsol Retention Enema
6. Contents of the pack and other information

1. What Predsol Retention Enema is and
what it is used for
Predsol Retention Enema 20mg/100ml Rectal
Solution (referred to as Predsol Retention Enema
in this leaflet) contains 20mg of the active
substance prednisolone as the sodium phosphate
ester.
Predsol Retention Enema belongs to a group of
medicines called steroids. Their full name is
corticosteroids.
These corticosteroids occur naturally in the body
and help to maintain health and well being.
Boosting your body with extra corticosteroids
(such as Predsol Retention Enema) is an effective
way to treat various illnesses involving
inflammation in the body. Predsol Retention
Enema reduces this inflammation, which could
otherwise go on making your condition worse.
You must use this medicine regularly to get the
maximum benefit.
Predsol Retention Enema is used to reduce

tenderness, heat and swelling in ulcerative colitis
and Crohn’s disease, where the bowel becomes
inflamed.
You must talk to a doctor if you do not feel
better or if you feel worse.

2. What you need to know before you use
Predsol Retention Enema
Do not use Predsol Retention Enema:
• if you are allergic to Prednisolone Sodium
Phosphate or any of the other ingredients of
this medicine (listed in section 6).
• if you are a child.
Warnings and precautions
Talk to your doctor or pharmacist before
using Predsol Retention Enema
• If you have ever had severe depression or
manic depression (bipolar disorder). This
includes having had depression before while
using steroid medicines like Predsol Retention
Enema
• If any of your close family has had these
illnesses.
If either of the above applies to you, talk to your
doctor before using Predsol Retention Enema.
•if you have recently been in contact with
someone who has chickenpox, shingles or measles,
or recently had chickenpox, shingles or measles
yourself. This product may make chickenpox,
shingles or measles much worse.
• if you have myasthenia gravis (an illness that
causes you to have weak muscles)
• if you have a bowel disease where you have
bloody diarrhoea
• if you have diverticulitis (a digestive disease)
• if you have osteoporosis (thinning of the
bones), as post-menopausal females are
particularly at risk

• if you have hypertension (high blood pressure)
• if you have a weakening of the heart (caused by
an underlying heart or blood vessel problem)
• if you have severe mental illness
• if you are diabetic or have a family history of
diabetes
• if you have, or have ever had tuberculosis (TB)
• if you or any of your family have ever had
glaucoma (raised eye pressure)
• if you have ever suffered from muscle wasting
due to corticosteroids
• if you have liver, kidney or heart disease
• if you have epilepsy (fits)
• if you have stomach or duodenal ulcers
• if you have stomach problems
• if you have an under-active thyroid gland
• if you have recently had a heart attack
• if you have just been or are about to be
immunised
• if you have an infection
• if you have undergone intestinal surgery
If any of the above applies to you, talk to your
doctor before using Predsol Retention Enema
Mental problems while using Predsol Retention
Enema;
Mental health problems can happen while
taking steroids like Predsol Retention Enema
(see also section 4 on possible side effects).
• These illnesses can be serious
• Usually they start within a few days or weeks
of starting the medicine
• They are more likely to happen at high doses
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However,
if problems do happen they might need
treatment.

Talk to a doctor if you (or someone who is
using this medicine), shows any signs of mental
problems. This is particularly important if you
are depressed, or might be thinking about
suicide. In a few cases, mental problems have
happened when doses are being lowered or
stopped.
Chickenpox, shingles or measles
You should avoid contact with anyone who has
either, chickenpox, shingles or measles as it
could be extremely serious if you caught it from
them.
Tell your doctor immediately if you suspect you
may have come into contact with a person who
has chickenpox, shingles or measles.
Children
The size of the Predsol Retention Enema bottle
means that this product is not suitable for
children.
Other medicines and Predsol Retention Enema
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
• Medicines to thin your blood (e.g. Warfarin
or Aspirin)
• Non-Steroidal Anti-Inflammatory Drugs
(NSAID) e.g. Ibuprofen or Aspirin
• Antibiotics (e.g. fluoroquinolones, rifampicin,
rifabutin or erythromycin)
• Medicines to treat diabetes (e.g. insulin)
• Medicines to treat epilepsy (e.g.
carbamazepine, phenytoin, primidone or
phenobarbital)
• Medicines to treat a fungal infection (e.g.
amphotericin or ketoconazole)
• Medicines to lower your blood pressure (e.g.

hydralazine)
• Medicines to treat a viral infection (e.g.
ritonavir)
• Water tablets (e.g. bendrofluazide)
• Medication that contains oestrogen (e.g.
contraceptives, hormone replacements, as may
become ineffective)
• Medicines for your heart (e.g. digoxin)
• Medicines to treat cancer (e.g. methotrexate
or aminoglutethimide)
• Medicines to suppress your immune system
(e.g. ciclosporin)
• Mifepristone (used for termination of
pregnancy)
• Medicines to treat myasthenia gravis (e.g.
anticholinesterases)
• Medicines that contain liquorice
• Medicines used to cause paralysis during
operations (e.g. neuromuscular blockers)
• Human growth hormone called somatropin
• Medicines for asthma (e.g. bambuterol,
formoterol, salbutamol, salmeterol,
terbutaline or theophylline)
• Medicines to treat ulcers (e.g. carbenoxolone)
• Live vaccines should not be taken by
individuals with a damaged immune system
• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you, talk to your
doctor or pharmacist.
Pregnancy
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
There is a small risk of cleft palate or retarded
growth in the foetus. Also, underactivity of the

adrenal glands may occur in a newborn child.
When steroids are essential, patients with
normal pregnancies may be treated as though
they are not pregnant. Patients with high blood
pressure or fluid retention require close
monitoring.
Breast-feeding
Small amounts of this medicine pass into breast
milk. Infants of mothers taking steroids should
be monitored carefully for signs of adrenal
suppression.
Driving and using machines
There are no known effects on driving or using
machines.
Predsol Retention Enema contains
parahydroxybenzoates which may cause allergic
reactions.

3. How to use Predsol Retention Enema
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Important:
Your doctor will choose the dose that is right for
you. Your dose will be shown clearly on the
label that your pharmacist puts on your
medicine. If it does not, or you are not sure, ask
your doctor or pharmacist.
The recommended dose is one enema used each
night for two to four weeks. After this,
treatment depends on how your body has
responded to the medicine.
Some people prefer a warm enema. If you do,
put the bottle in warm water for a few minutes
before use.

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Hold the bottle upwards and remove the cap.
Attach the nozzle.
Place your hand in the protective plastic bag.
Grease the nozzle with petroleum jelly.
Lie in bed on the left side with knees drawn up
(semi-prone position). Gently insert about half
the length of the nozzle into your rectum (back
passage). Squeeze the bottle until all the liquid
goes into your back passage, taking a minute or
so to do it. Slowly remove the nozzle from your
back passage making sure that no liquid goes
back into the bottle.

6. Invert the plastic bag around the bottle and
discard the whole unit without getting up from
the semi-prone position.
7. Roll over and lie face down for 3 to 5 minutes.
You can then go to sleep in any comfortable
position.
While you are using this medicine, your doctor
may ask you to have check-ups. These are to
make sure that your medicine is working
properly and that the dose you are using is right
for you.
If you use more Predsol Retention Enema than
you should
Do not use more Predsol Retention Enema than
you should. If you accidentally use two enemas
within a shorter period of time than prescribed by
your doctor, let your doctor know. Treatment is
unlikely to be needed in cases of serious overdose.

If you forget to use Predsol Retention Enema
If you forget to use your enema, contact your
doctor who will tell you what to do. If you only
remember at the time of your next enema, use a
single enema and continue as usual. Do not take a
double dose to make up for the missed dose.
If you stop using Predsol Retention Enema
Do not stop using Predsol Retention Enema
without first talking to your doctor.
It is very important that you do not suddenly stop
using Predsol Retention Enema even if you feel
better, unless your doctor tells you to.
If you stop using your medicine too suddenly, you
may suffer from some of the following: Fever,
joint and muscle pain, itching eyes, nose or skin,
mood changes, loss of weight, low hormone levels,
and low blood pressure, symptoms of which may
include dizziness, headaches, or fainting. In
extreme cases this can be fatal. Your doctor will
tell you how to stop using Predsol Retention
Enema.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Steroids including Prednisolone can cause serious
mental health problems, and the following very
serious effects may occur.
• Breaking and rupture of tendons
• Allergic reactions (which can include rashes,
breathing difficulties or shock)
• Anaphylaxis (which is a severe, potentially life
threatening allergic reaction caused by nuts,
shellfish, dairy products and insect stings that
can develop rapidly)
• Obstruction of a blood vessel by a blood clot

(thromboembolism)
• Inflammation of the pancreas which develops
quickly, symptoms include severe upper
stomach pain, often with nausea and vomiting
(acute pancreatitis)
• Toxic epidermal necrolysis - a severe skin
reaction which starts with painful red areas,
then large blisters and ends with peeling of
layers of skin. This is accompanied by fever
and chills, aching muscles and generally felling
unwell
• Headaches, blurred vision, enlargement of blind
spot, dimming or blackout of vision, and
ultimate loss of vision
• Becoming dependent on something to help
alleviate specific emotions (psychological
dependence).
These are common in both adults and children.
Common: may affect up to 1 in 10 people
• Feeling irritable.
• Having delusions.
• Having behaviour problems.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and
losing your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
• Worsening of schizophrenia if you already have
this problem
If you notice any of these problems talk to a
doctor straight away.
Not known: frequency cannot be estimated

from the available data.
• Worsening of tuberculosis (TB) if you already
have this problem
• Increased risk of infection
• Higher blood pressure
• Changes in blood test results for lipids (e.g.
cholesterol)
• Symptoms resembling leukaemia, white blood
cell count is raised in response to an allergy,
infection or severe physical stress (leukemoid
reactions)"
• Suppression of growth in infants, children and
adolescents
• Irregular periods, or your periods may stop
altogether
• A round, usually red face (Cushingoid facies)
• Acne or extra hair growth
• Weight gain or increased appetite
• Intolerance to carbohydrates which might result
in a requirement for anti-diabetic treatment
• Loss of protein and calcium balance
• Worsening of epilepsy if you already have this
problem
• Increased pressure in the eye (glaucoma)
• Cataracts
• Worsening of viral or fungal eye diseases
• Thinning of the cornea or sclera (the outer wall
of the eye)
• Detachment of the retina
• If you have recently had a heart attack,
prednisolone can cause the tissues of the heart
to tear
• Severe stomach pain
• Stomach ulcers which may bleed
• Thrush in the mouth or throat
• Feeling sick, hiccups, heartburn or indigestion
• Prominent veins or thinning of the skin

• Bruising or poor wound healing
• Appearance of stretch marks
• Inflammation of the skin, abscesses or changes
in skin colour
• Separation of the top layer of the skin from the
lower skin layers
• Thinning of the bones (osteoporosis)
• Spine, arm and leg fractures
• Wasting of muscles
• Salt and water retention in the body
• Lack of, or extreme loss of, the normal amount
of potassium
• Abnormal increase in the number of white
blood cells (leucocytosis)
Additional care should be taken if this medicine is
given to elderly patients, as side-effects may be
more serious.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme on the
MHRA website (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Predsol Retention Enema
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and bottle after EXP.
The expiry date refers to the last day of that
month.
Do not store above 25°C. Keep the bottle in the
outer carton in order to protect from light.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other
information
What Predsol Retention Enema contains
The active substance is Prednisolone Sodium
Phosphate. Each 100ml bottle contains 20mg
Prednisolone (as Prednisolone Sodium Phosphate).
The other ingredients are Nipastat, Disodium
edetate, Sodium acid phosphate, Disodium
phosphate anhydrous, Sodium hydroxide and
purified water.
What Predsol Retention Enema looks like and
contents of the pack
Predsol Retention Enema Rectal Solution is a clear
liquid in a 100ml plastic bottle with a separate
nozzle and a separate plastic bag. Each bottle,
nozzle and plastic bag is only used once.
A pack contains seven bottles, seven nozzles and
seven plastic bags.
Marketing Authorisation Holder
RPH Pharmaceuticals AB
Lagervägen 7,
136 50 Jordbro,
Sweden
Distributed in the UK by Focus Pharmaceuticals
Ltd.

Carrying your steroid card
• If your doctor asks you to carry a steroid card,
be sure to keep it with you always.
• Show it to any doctor, dentist, nurse or midwife
or anyone else who is giving you treatment.
• Even after your treatment has finished tell any
doctor, dentist, nurse, midwife or anyone else
who is giving you treatment that you have had
steroid treatment.
A steroid card may be obtained from your doctor,
pharmacist, or local Family Health Service
Authority. In Scotland, steroid cards are available
from the Scottish Office of Home and Health.

This leaflet was last revised in January 2015.

If this leaflet is difficult to see or read or
you would like it in a different format,
please contact
RPH Pharmaceuticals AB
Lagervägen 7,
136 50 Jordbro,
Sweden

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.